FDA 510(k) Applications Received During September, 2015

FDA 510(k) Number Submission Date Device Name Applicant Contact
K152524 09/03/2015 Entuit Secure Gastrointestinal Suture Anchor Set, Entuit Secure Adjustable Gastrointestinal Suture Anchor Set COOK INCORPORATED ERUM B. NASIR
K152526 09/03/2015 Elecsys Progesterone III CalSet ROCHE DIAGNOSTICS Patty Bates
K152545 09/08/2015 DC-60/DC-60S/DC-60 EXP/DC-55 Diagnostic Ultrasound Systems SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD YANG ZHAOHUI
K152523 09/03/2015 JBAIDS Influenza A & B Detection Kit U.S. ARMY MEDICAL MATERIEL DEVELOPMENT ACTIVITY ROBERT E MILLER


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